5. REGULATORY FRAMEWORK

This Chapter outlines the Regulatory Framework for the Detailed Statement of Policy (the Policy) for Scotland's higher activity radioactive waste (the Waste). It explains:

the Scottish Government's position on the regulation, scrutiny and control of the management of the Waste;

who will regulate the Waste; and

how the Waste will be regulated.

This Chapter should be read in conjunction with:

the Environmental Report which considers the Policy proposals and reasonable alternatives to them and assesses their environmental implications; and

Section 3 of the Supplementary Information which gives more information on the regulatory and legislative framework for managing the Waste.

5.01 Regulatory Principles

5.01.01 The Scottish Government is committed to strong and effective control and regulation of the management of the Waste and this will be enforced by the relevant independent regulatory bodies. This Policy will not alter the existing legislative and regulatory arrangements. Regulators, waste producers and owners must abide by the Scottish Government Policy.

5.01.02 There is a comprehensive and well established legislative, regulatory and planning framework in Scotland for the management of the Waste and development of facilities currently in place. Robust, effective and independent regulation is vital for public confidence in the management of the Waste to meet high safety, security and environmental standards based on comprehensive risk assessment and management. Scottish Ministers will exercise their powers under relevant legislation where appropriate.

5.01.03 Engagement and consultation is already the practice for, or a requirement of, a number of bodies and of specific legislation. There will be opportunities for more formal engagement with stakeholders as part of the regulatory and planning consent processes which will be needed to manage the Waste.

5.01.04 The Scottish Government expects:

continued involvement of the regulators throughout the waste management process;

all aspects of regulatory decision making, except those which could prejudice national security or commercial confidentiality, to be open and transparent and provide opportunity for input and assessment of public and stakeholder views;

developers and operators to engage at an early stage with local communities and the relevant regulatory and permitting authorities to ensure their views are taken into account when plans for storage or disposal, or any other, facilities are being developed; and

the Nuclear Decommissioning Authority ( NDA), its contracting Site Licence Companies and any other waste owners and producers to comply with the appropriate regulatory requirements.

5.02 Who Regulates the Waste?

5.02.01 The regulatory regime is delivered principally through the following bodies:

Scottish Environment Protection Agency

5.02.02 The Scottish Environment Protection Agency ( SEPA) is Scotland's environmental regulator. SEPA's main role is to protect and improve the Scottish environment by regulating activities that can cause harmful pollution. SEPA also has responsibility for carrying out monitoring of the quality of Scotland's air, land and water. The regulations SEPA implements also cover the keeping, use, accumulation and disposal of certain radioactive substances on certain premises.

Health and Safety Executive

5.02.03 The Health and Safety Executive ( HSE) is the statutory body responsible for the enforcement of health and safety law on nuclear sites in Great Britain. HSE is the licensing authority for nuclear installations in Great Britain and, through its Nuclear Installations Inspectorate ( NII), regulates the nuclear, radiological and industrial safety of nuclear installations. The NII regulates the keeping and use of radioactive material and the storage of radioactive waste on Nuclear Licensed sites under this regime.

Office for Civil Nuclear Security

5.02.04 The Office for Civil Nuclear Security ( OCNS) is a Division within HSE's Nuclear Directorate responsible for regulating security arrangements in the civil nuclear industry, including security of nuclear material in transit, exercising statutory powers on behalf of the Secretary of State for Business, Innovation and Skills ( BIS).

Department for Transport

5.02.05 Regulation of the safety of radioactive material transport packages in Great Britain ( GB) is the responsibility of the Department for Transport (DfT). The DfT exercises its statutory powers of enforcement on behalf of the Secretary of State for Transport for the transport of radioactive material by road, and for package designs for all modes of transport. Enforcement during carriage by rail is the responsibility of the Office of the Rail Regulator ( ORR). Enforcement during carriage by sea is the responsibility of the Maritime and Coastguard Agency ( MCA).

5.03 What Regulations Govern the Management of the Waste?

Co-ordination of regulatory requirements

5.03.01 There are a number of different regulatory requirements for the management of the Waste. The Policy will not change these requirements; however, any future changes to legislation or regulation would need to be taken into account when applying the Policy. Regulatory requirements need to be appropriately co-ordinated as part of an application and approval process to ensure that they are applied for at appropriate stages and obtained in the correct order. The following paragraphs summarise the key requirements that would apply to the development of a facility. Section 3 of the Supplementary Information provides more detail.

Safety regulation - Nuclear site licensing

5.03.02 The legislation for licensing safety requirements of a nuclear installation is the Nuclear Installations Act 1965 ( NIA65) ( Ref 13). Where a new site is to be licensed, or where an existing site is to be relicensed to accommodate the introduction of an additional class of prescribed activity, the Health and Safety Executive ( HSE) will scrutinise the developing design safety case to assess whether the operations at the site will be adequately safe.

5.03.03 Granting of a nuclear site licence is dependent on HSE's satisfactory assessment of this safety case. Licence conditions cover all aspects of nuclear safety relating to the development of the facility and arrangements made under them will provide for a series of construction and operational hold points e.g. consent to start construction or excavation, consent to start commissioning, etc. Before work can proceed beyond a hold point, the Health and Safety Executive will need to be satisfied that the proposed activity following the hold point is backed by a satisfactory safety case submission.

5.03.04 After completion of operational and decommissioning activities on a nuclear licensed site, the site remains under the nuclear site licensing regime until the licence holder is able to demonstrate to the safety regulator that it is appropriate to end the 'period of responsibility'.

Environmental regulation

5.03.05 A nuclear installation where the Waste is produced will require an authorisation granted by SEPA under the Radioactive Substances Act 1993 ( RSA93) ( Ref 14) in order to dispose of any radioactive waste or to transfer radioactive waste to another facility. Any disposals, whether discharges of gas to atmosphere or liquid to drains, or transfers of solid waste to another facility for further treatment or final disposal, will have to meet stringent conditions and limits set by SEPA. When setting the conditions and limitations in an authorisation, SEPA will take account of a wide range of national and international guidance, standards and principles, so as to protect the health and interests of people and the integrity of the environment.

5.03.06 An authorisation under RSA 93 is not required to store or manage radioactive waste on a nuclear installation because, in this instance, these activities are regulated by HSE under CoRWM, as described above.

5.03.07HSE and SEPA have agreements to work closely together when regulating nuclear installations. HSE frequently consults with SEPA regarding radioactive waste management activities, enabling SEPA to judge whether any particular activity gives any cause for concern from an environmental perspective. In the case of the management of Waste for long-term storage or disposal, these consultation arrangements have been strengthened and formalised so as to improve regulatory control and coordination. The improved arrangements are described in a suite of documents under the title of "The management of higher activity radioactive waste on nuclear licensed sites: Guidance from the Health and Safety Executive, the Environment Agency and the Scottish Environment Protection Agency to nuclear licensees" (also known as the Joint Guidance) ( Ref 15).

5.03.08 The Joint Guidance aims to set out clearly for nuclear site licensees HSE's and SEPA's shared regulatory objectives for the long-term management of the Waste. It introduces the concept of:

a radioactive waste management case as a means of keeping track of the inter-relationships between the different processes that will affect a given radioactive waste stream from "cradle to grave"; and

providing a clear summary of the reasoning and justification for a chosen waste management option.

5.03.09 The Joint Guidance benefits nuclear site licensees as well as providing greater transparency for the regulators on how licensees are managing their waste. It promotes improved co-ordination which should minimise the possibility of conflicting requirements being placed on licensees by the regulators. Licensees are also encouraged to discuss their long-term waste management plans with both regulators as early as possible; this will reduce (though not remove altogether) the risk that they expend time, effort and money in developing a plan only for a regulator to object at a later stage.

Security regulation

5.03.10 The Office for Civil Nuclear Security ( OCNS) regulates security in the civil nuclear industry exercising powers on behalf of the Secretary of State for Energy and Climate Change. OCNS' activities include the regulation of physical security at civil licensed nuclear sites and the transport between sites of nuclear material by road and rail throughout the UK. In response both to the Hampton report and to the changes in the UK's nuclear industry and in the interests of promoting effective, integrated regulation, OCNS merged with the HSE's NII and the UK Safeguards Office in April 2007 to form the Nuclear Directorate of the HSE.

Transport regulation and transport package approval

5.03.11 Waste will need to be transported safely from waste producers to any facility for the treatment, packaging, storage or disposal of the Waste. The requirements for the safe transport of radioactive material by road, rail and sea are derived from international agreements and European Directives. These requirements have been implemented in UK legislation setting out what types of transport package are allowed, how much radioactivity they are allowed to contain, and how they should perform against specified tests. The requirements are based upon a graded approach to safety, where the design and test requirements for packages become more stringent as hazard potential increases. The international regulatory framework upon which GB radioactive material transport regulations are based is well established by differs from much of GB health and safety legislation in that the requirements are more prescriptive than goal-setting.

5.03.12 Approval from the transport safety regulator is required for certain package designs and shipments. The transport safety regulator responsible for granting approvals is the DfT, and enforcement powers are allocated between DfT, Office of the Rail Regulator ( ORR) and the Maritime and Coastguard Agency ( MCA). DfT operates a compliance assurance programme where duty-holders are subject to risk-based audit and inspection of their activities. The compliance assurance programme includes audit and inspection of the consignment and carriage of radioactive material and package designs that do not require approvals or consents from DfT as the safety regulator, as well as those that do.

Justification

5.03.13 European legislation requires that any new practice involving ionising radiation initiated on or after 13 May 2000 needs a justification decision ( Ref 16) from the Member State that the benefits of the practice outweigh any detriment to health that might be caused by exposure to radiation. Guidance from the International Commission on Radiological Protection ( ICRP) and on behalf of the Justifying Authorities, states that waste management and disposal operations are an integral part of the practice that generates the waste and it is inappropriate to regard them as free-standing practices that require their own justification.

Planning regulation

5.03.14 Planning permission will be required for the construction of a radioactive waste storage or disposal facility under the Planning etc (Scotland) Act 2006. In Scotland it is generally the local authority which is the planning authority responsible for considering any application for such a store. Notification to the Scottish Ministers is required for applications where the authority has an interest on those occasions where the development would involve a significant departure from the development plan, when the national interest is engaged in planning applications or where central government departments or agencies have raised objections to a proposed development, due to potential implications for their interests. Guidance is provided in Circular 3/2009 ( Ref 17).

5.03.15 Public and community engagement is an important element of our modernised planning system in relation to development planning (guidance is provided in Circular 1/2009) ( Ref 18) and development management (guidance is provided in Circular 4/2009) ( Ref 19). It is likely that a radioactive waste storage or disposal facility would require mandatory environmental impact assessment thereby classing it as a "major" development in the planning hierarchy (guidance is provided in Circular 5/2009) ( Ref 20). Statutory pre-application consultation is required in relation to any development classed as a major development. Further advice on community engagement is provided in Planning Advice Note 81 ( Ref 21).

Assessment of environmental effects

5.03.16 The Environmental Assessment (Scotland) Act 2005 requires that plans, programmes and strategies (including policies) likely to have significant effects on the environment are subject to an environmental assessment prior to their adoption. This process is known as Strategic Environmental Assessment ( SEA) and ensures that environmental information is taken into account by decision-makers. SEA is undertaken alongside policy preparation and facilitates development of the policy such that, where appropriate, effects can be identified at an early stage and appropriate measures for their mitigation determined. SEA requires public consultation at key stages.

5.03.17 The Environmental Impact Assessment (Scotland) Regulations 1999, as amended, also requires that certain individual projects are subject to Environmental Impact Assessment ( EIA). The environmental information so provided is to be taken into account by the decision-maker when considering the application for project consent.

5.03.18 This Policy has been subject to SEA and the Consultation Document is accompanied by an Environmental Report, which sets out the environmental effects of the policy and identifies measures for their mitigation. SEA of the Strategy to implement the Policy will be required to inform any site selection process in the future. The Scottish Government is committed to ensuring that the development of individual storage or disposal facilities will take environmental issues into account, through application of the EIA process.

In considering your responses to the questions please take account of the information in the Consultation Document as a whole, not just this Chapter, as well as the information in the Environmental Report and the Supplementary Information document.

Chapter 5

Question CD19

Have we adequately explained the Regulatory Framework for managing the Waste in Scotland?